LOWENSTEIN medical JOYCEeasy Nasal Mask Instruction Manual

LOWENSTEIN medical JOYCEeasy Nasal Mask

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Operation

The figures show the following steps for operating the mask:

1. Putting on the mask
   

2. Adjusting the mask
   

3. Removing the mask
   

4. Dismantling the mask
   

5. Assembling the mask
   
   

For blind and partially-sighted users An electronic version of the instructions for use is also available on the manufacturer’s website

Introduction

Intended use

The JOYCEeasy mask is used for treating sleep apnea and for non-invasive and non-life-sustaining ventilation of patients with respiratory insufficiency. It serves as a link between the patient and the ventilator.

Contraindications

The mask must not be used on patients weighing < 30 kg.

The mask must not be used in the following situations: Immediate intubation required, loss of consciousness, acute vomiting.

The mask may be used in the following situations only with particular caution: Pressure points and acute injuries to the skin of the face; skin allergies involving the face; deformities of the face or nasopharynx; acute pain affecting the face; cough reflex restricted or absent; claustrophobia; acute nausea. If you are not sure whether one of these situations applies to you, consult your healthcare professional. Observe the contraindications in the instructions for use of your device.

Side effects

The following side effects may occur with use of the mask: Nasal congestion, dry nose, dry mouth in the morning, feeling of pressure in the sinuses, irritated conjunctiva, skin rashes, pressure marks on the face, irritating noises when breathing.

If these side effects occur, contact your healthcare professional.

Clinical benefit

Transfers the therapeutic efficacy of the ventilator to the patient

Safety

Risk of injury due to damaged mask parts or those under strain!

⇒ Perform a visual inspection before every use and after every cleaning operation.
⇒ Note useful life (see section entitled “Technical Data”).
⇒ Replace mask parts if necessary.

Risk of injury due to the use of oxygen!

Oxygen can become deposited in clothing, bedlinen, and hair. Supplying oxygen without a safety device can lead to fire.

⇒ Use an oxygen safety valve.
⇒ Follow the instructions for use for the oxygen supply system.
⇒ Set up oxygen sources at a distance > 1 m from the device.
⇒ Do not smoke.
⇒ Avoid naked flames.
⇒ Ventilate the room well.
⇒ Keep mask free from oil and grease.

Risk of injury due to patient receiving inadequate supply!

⇒ Activate low pressure/leakage alarms on the ventilator.
⇒ Use the appropriate mask size and check that it is securely in position.
⇒ Monitor patients with restricted spontaneous breathing.

Risk of injury from re-inhalation of CO2!

⇒ Only use the mask when therapy is in progress.
⇒ Only use the mask within the quoted therapy pressure range.
⇒ Patients unable to remove the mask themselves must be monitored by a nurse.
⇒ Do not close off exhalation systems.

Risk of injury due to escape of anesthetic gas or atomization of drugs!

⇒ Do not use the mask during anesthesia.
⇒ Do not use the mask to atomize drugs.
⇒ Clean mask parts before using for the first time (see section entitled “Cleaning and reprocessing”).
⇒ Clean the mask regularly. ⇒ When selecting a detergent, consider potential allergies.
⇒ On change of patient in a hospital environment: Comply with the document entitled Information on reprocessing (see section entitled “Reprocessing”)
⇒ For patients with a compromised immune system or particular background of illness, disinfect mask parts daily following consultation with the healthcare professional.

Product description

A diagram of the individual parts can be found on the title page.

Compatible devices

In some device combinations, actual pressure does not correspond to the therapy pressure displayed by the device. Have the device adjusted by a healthcare professional so that actual pressure in the mask corresponds to therapy pressure. This setting should be made using the type of mask used during therapy.

Exhalation system

The mask has an integrated exhalation system. The exhaled air escapes through a gap

Cleaning and reprocessing

Clean mask

1. Wash your hands before starting cleaning.
2. Dismantle mask (see Figure  4 ).
3. Wash mask by hand (max. 30 °C, 1 ml mild detergent in 1 l water) in accordance with the table below:
   Mask part| Frequency| Action
   ---|---|---
   All mask parts| Daily
   Soak and wash for 15 minutes and clean for 3 minutes using a soft cleaning brush.
   Headgear| Weekly Wash for 15 minutes.

All parts can be washed in a dishwasher once a week (max. 70 °C, mild detergent, max. program length 90 minutes, top basket, separate rinse).

4. Rinse all parts with clean water.
5. Allow all parts to air-dry.
6. Perform a visual inspection for cracks and deformation. Replace damaged parts. Discoloration is not a problem.
7. Assemble mask (see Figure 5 ).

Reprocessing (clinical environment)

In the event of a change of patient, follow the instructions in the document entitled Information on reprocessing. The document can be found on the manufacturer’s website. We will send you the document on request.

Disposal

Dispose of the mask in domestic waste. In the clinical environment: Dispose of the mask in accordance with hospital regulations.

Troubleshooting

Technical data

Dimensions in mm
(W x H x D)
Size S
Size M
Size L| 100 X 100 X 80
105 X 110 X 80
110 X 120 X 80
---|---
Weight
Size S
Size M
Size L| 94 g
97 g
98 g
Dead space
Size S
Size M
Size L| 100 ml
105 ml
115 ml
Tube Connection: Tapered connection to EN ISO 5356-1| 0 22 mm (male)
Flow resistance at 50 I/min at 100 I/min| 0.3 hPa 1.0 hPa
Service life| 5 years
---|---
Useful life| Up to 12 months 1
Therapy pressure| 4 hPa – 30 hPa
Quoted two-figure noise emission value according to ISO 4871:
Sound pressure level Sound power level Uncertainty factor| 17 dB(A)
25 dB(A)
3 dB(A)
Temperature: Operation
Transport and storage| +5 °C to + 40 °(
-20 °C to +70 °C
Standards applied| EN ISO 17510: 2020
Product class to MDR (EU) 2017/745| Ila
1 Useful life depends on cleaning and on the detergents used, on the amount of time worn daily, on therapy pressure, and on individual secretion of sweat. Using the second mask cushion (included as an option) does not extend useful life.

Materials

No parts of the mask contain latex, PVC (polyvinyl chloride) or DEHP (trimethylphenyl phthalate). In the event of allergies to the materials listed, only use the mask following agreement with the healthcare professional.

Characteristic pressure/flow curve

Markings and symbols

The following markings and symbols may be applied to the device, accessories or packaging.

directives/regulations)
| Permitted temperature range for transport and storage
| Use by date
| Keep out of sunlight

Warranty

Löwenstein Medical Technology gives the purchaser of a new original Löwenstein Medical Technology product and of a spare part fitted by Löwenstein Medical Technology a limited manufacturer warranty in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase listed below. The warranty conditions are available on the manufacturer’s website. We will also send you the warranty conditions on request.

Please bear in mind that any claim under warranty and liability shall be void if neither the accessories recommended in the instructions for use nor genuine spare parts are used.

In the event of a claim under warranty, contact your specialist dealer.

Declaration of Conformity

The manufacturer Löwenstein Medical Technology GmbH + Co. KG (Kronsaalsweg 40, 22525 Hamburg, Germany) hereby declares that the product complies with the relevant provisions of the Medical Device Regulations (EU) 2017/745. The unabridged text of the Declaration of Conformity can be found on the manufacturer’s website.

In the EU: As a user and/or patient, you must report any serious incidents occurring in conjunction with the product to the manufacturer and to the responsible authority.

Customers Support

Manufacturer
Löwenstein Medical
Technology GmbH + Co.KG
Kronsaalsweg 40
22525 Hamburg, Germany
T: +49 40 54702-0
F: +49 40 54702-461
www.loewensteinmedical.com

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